| Study | Exclusion reasons | Rmk | Reference |
|---|---|---|---|
| Pinheiro, 2018 | inadequate or absent control group | EXCLUDED: all pregnancies exposed to Quetiapine. All women had full term infants, and no adverse birth outcomes were reported. |
Pinheiro Journal of Clinical Psychopharmacology. 2018;38(1):89–91 |
| Shao (Clozapine versus other atypical antipsychotics), 2015 | inadequate or absent control group | Disagreement with authors who defined this study as a prospective, case-controlled study rather than a cohort. |
Shao P PLoS One 2015;10:e0123373 10.1371/journal.pone.0123373 |
| Hatters, 2016 | inadequate or absent control group | EXCLUDED: no control group. |
Hatters Friedman Int J Psychiatry Med 2016; 51:521-533 10.1177/0091217417696739 |
| Grover, 2025 | inadequate or absent control group | Case series |
Grover J Clin Psychopharmacol 2025; : 10.1097/JCP.0000000000002013 |
| Damer, 2024 | inadequate or absent control group | EXCLUDED: All pregnant women exposed to psychotropics (atypical antipsychotic drugs, SSRI, Tricyclic Antidepressants (TCA), benzodiazepines, and different combinations) => No adequate control group. |
Damer Gen Hosp Psychiatry 2024; 90:76-83 10.1016/j.genhosppsych.2024.06.015 |
| Kulkarni, 2014 | inadequate or absent control group | EXCLUDED: Comparison with an extern comparator ('Expected rate in Australia'). |
Kulkarni PLoS ONE 2014; 9:e94788 10.1371/journal.pone.0094788 |
| Galbally - Aripiprazole only, 2018 | inadequate or absent control group | EXCLUDED: pregnancies included in the control group exposed to aripiprazole during pregnancy (they have ceassed during pregnancy but at an unknown time). |
Galbally J Affect Disord 2018; 238:593-596 10.1016/j.jad.2018.06.004 |
| Dev, 1995 | case report or case series | EXCLUDED: all pregnancies exposed to clozapine => No control group. | |
| Paulzen, 2018 | case report or case series | EXCLUDED: all pregnancies exposed to Quetiapine, no control group. |
Paulzen Schizophr. Res. 2018; 195:252-257 10.1016/j.schres.2017.09.043 |
| Babu (Olanzapine versus other psychotropics), 2010 | other reason | EXCLUDED because continuous variable and because all groups were prenatally exposed to antipsychotics (olanzapine for exposed group and psychotropics for unexposed group, probably with atypical antipsychotics). |
Babu GN J Clin Psychopharmacol 2010;30:331-2 10.1097/JCP.0b013e3181db8734 |
| Freeman, 2018 | other reason | EXCLUDED: Continuous variable. Study with the same protocol that Cohen 2016 and 2018 related to malformations (atypical antipsychotics and quetiapine respectively) |
Freeman MP Psychosomatics 2018;59:125-134 10.1016/j.psym.2017.09.002 |
| Kulkarni, 2008 | other reason | EXCLUDED: no findings related to the outcomes (presentation of the register and of the first 30 participants) |
Kulkarni J Aust N Z J Psychiatry 2008;42:38-44 10.1080/00048670701732723 |
| Cohen, 1995 | not relevant exposure | EXCLUDED: exposure: lithium, antidepressant and/or carbamazepine. |
Cohen Am J Psychiatry 1995; 152:1641-5 10.1176/ajp.152.11.1641 |
| Boden, 2012 | not relevant exposure | EXCLUDED: no sub-analyse of Atypical antispychotics. Treated bipolar disorder group included women treated with lithium, antipsychotics, carbamazepine, lamotrigine and valproate. | |
| Diav-Citrin, 2005 | not relevant exposure | EXCLUDED: no analyse of Atypical antipsychotics (only butyrophenone neuroleptics haloperidol and penfluridol). | |
| Auerbach, 1992 | not relevant exposure | EXCLUDED: no Atypical antipsychotic in utero exposure. Abstinence syndrome score. 2 control groups: 'Pregnant women diagnosed as having no mental illness' and 'Pregnant women with a psychiatric diagnosis but not treated pharmacologically during pregnancy' | |
| Steinberg, 2018 | not relevant exposure | 'We included 3 measures to assess the woman’s mental health history: (1) prior inpatient or outpatient psychiatric admission (all ICD-10 codes in chapter F, mental and behavioral disorders), (2) prior use of antipsychotic medications (ATC code N05A),' |
Steinberg JAMA Psychiatry 2018; 75:828-834 10.1001/jamapsychiatry.2018.0849 |
| Rosch, 2002 | not relevant exposure | EXCLUDED: No data on Atypical antipsychotic. The DP women had higher drug dosages overall when groups were compared on antipsychotic dosage by chlorpromazine equivalencies (trend nearing statistical significance, t = 1.48, with df = 20, p = .08). |
Rosch DS Int J Psychiatry Med 2002;32:295-303 10.2190/VRV7-7H3T-F5WF-A4B7 |
| Stika, 1990 | not relevant exposure | EXCLUDED: no Atypical antipsychotic in utero exposure. Neuroleptics consisted in chlorpromazine and chlorprothixene. | |
| Tran, 2017 | not relevant exposure | EXCLUDED: no atypical antipsychotic are a reactive intermediate (RI)-inducing drugs or a drug exhibiting folic acid antagonism (FAA). |
Tran YH Pharmacoepidemiol Drug Saf 2017;26:265-273 10.1002/pds.4161 |
| Lin, 2022 | not relevant exposure | EXCLUDED: Second-generation antipsychotic (SGA) group included a First-generation antipsychotic (FGA) sulpiride (n=284 ; 17.3%) => Not adequate exposure (at more than 10%). |
Lin Mayo Clin Proc 2022; 97:2086-2096 10.1016/j.mayocp.2022.04.006 |
| Galbally, 2020 | not relevant exposure | EXCLUDED: Gestational diabetes not reported because not sure that exposure occurred before outcome. |
Galbally Aust N Z J Obstet Gynaecol 2020; 60:63-69 10.1111/ajo.12986 |
| Rieder, 1975 | not relevant exposure | EXCLUDED: no analyse on atypical antipsychotic (typical medications were used). Primary analyses/ results related to illness (no correlation for phenotiazines). | |
| Godet, 1991 | not relevant exposure | EXCLUDED: studied neuroleptics (chlorpromazine, fluphenazine, haloperidol, flupenthixol, sulpiride, metoclopramide, metopimazine, phenothiazine, butyrophenone) did not included atypical antipsychotics. | |
| Calderon-Margalit, 2009 | not relevant exposure | EXCLUDED: Not related to atypical antipsychotics (study in relation with 'women who used SSRIs, selective norepinephrine receptor inhibitors (SNRI), or BZD'). |
Calderon-Margalit Am. J. Obstet. Gynecol. 2009; 201:579.e1-8 10.1016/j.ajog.2009.06.061 |
| Makikyro, 1998 | not in pregnancy | EXCLUDED: no exposure during pregnancy. Characteristics of pregnancy, delivery, childhood (etc.) of men and women treated for schizophrenia assessed as potential factors for the psychotropic treatment. | |
| Gilad, 2011 | not about fetal exposure | EXCLUDED: comparison of children breastfed or not with Olanzapine, not according to exposure during pregnancy. | |
| Wieck, 2010 | not relevant outcome | 'the clinic recommended to continue the same medication in 9 cases (28.1%), to stop medication treatment in 4 cases (12.5%), and to switch to different agents in 19 cases (59.4%).' |
Wieck J Clin Psychiatry 2010; 71:806 10.4088/JCP.09l05596yel |
| Westin, 2018 | not relevant outcome | 'To study infant outcomes was beyond the scope of the present study.' |
Westin Clin. Pharmacol. Ther. 2018; 103:477-484 10.1002/cpt.770 |
| Bilszta, 2010 | not relevant outcome | EXCLUDED: studied outcomes 'sleep⁄wake activity' and 'relapse events'. No data on maternal/fetal/neonatal safety. |
Bilszta Bipolar Disord 2010; 12:568-78 10.1111/j.1399-5618.2010.00845.x |
| Platt, 1988 | not relevant outcome | EXCLUDED: continuous variables (mean weight, height). | |
| Taylor, 2018 | not relevant outcome | EXCLUDED: study related to relapse in pregnancy. Medication (without details on the substances) studied as a potential predictor of relapse in pregnant women. |
Taylor J Psychiatr Res 2018; 104:100-107 10.1016/j.jpsychires.2018.06.019 |
| Hanley, 2018 | not relevant outcome | EXCLUDED: study related to Health services use during pregnancy or the one-year preconception among women with an indication of depression during their pregnancy, according to by income quintile. |
Hanley Arch Womens Ment Health 2018; 21:765-775 10.1007/s00737-018-0866-6 |
| Liu, 2022 | data not abstractable | EXCLUDED: Aberrant values obtained using conversion of continuous values to OR (due to unmet assumptions of continuous distribution) => additional analyses of the study (including breaking down by type of antidepressants) not available (author's reply). |
Liu JAMA Intern Med 2022; 182:1035-1043 10.1001/jamainternmed.2022.3388 |
| Cohen (Quetiapine only, all atypical antipsy in Cohen 2016), 2018 | repeat population groups, duplicate reports (most recent study included) | EXCLUDED: study related to Quetiapine only (period 2008-2017; n=155) whereas Cohen et al., 2016 related to all second-generation antipsychotics (period 2008-2014 ; n=214) . |
Cohen LS Am J Psychiatry 2018;:appiajp201818010098 10.1176/appi.ajp.2018.18010098 |
| Cohen, 2016 | repeat population groups, duplicate reports (most recent study included) | EXCLUDED: Overlapping: study updated by Viguera 2021. Study with the same protocol that Cohen 2018 related to Quetiapine, but the study period is not the same (2008 - 2017 for Quetiapine). |
Cohen LS Am J Psychiatry 2016;173:263-70 10.1176/appi.ajp.2015.15040506 |
| Malm (Control exposed to other treatments), 2018 | repeat population groups, duplicate reports (most recent study included) | Two studies created: one for each control group: pregnancy outcome in S-GA users was compared to the two comparison groups (exposed to first generation antipsychotics and unexposed control) using logistic regression models. | |
| Freeman (Aripiprazole only, all atypical antipsy in Cohen 2016), 2021 | repeat population groups, duplicate reports (most recent study included) | Overlapping: This study (Aripiprazole; 2008 - 2020; n=163) has the same database (NPRAA), protocol and outcomes that Cohen 2016 (all atypical antipsychotics ; 2008 - 2014 ; n=214) but for only 1 substance => excluded of this meta-analysis. |
Freeman Arch Womens Ment Health 2021; 24:659-667 10.1007/s00737-021-01115-6 |
| Malm (Unexposed control), 2018 | repeat population groups, duplicate reports (most recent study included) | Two studies created: one for each control group: pregnancy outcome in S-GA users was compared to the two comparison groups (exposed to first generation antipsychotics and unexposed control) using logistic regression models. | |
| Sutter-Dallay, 2010 | repeat population groups, duplicate reports (most recent study included) | EXCLUDED: these data (study period 2001-2007) were updated and published by Sutter-Dallay 2015 (study period 2001-2010). |
Sutter-Dallay, A.-L. Annales Medico-Psychologiques 2010; 168:628-. 10.1016/j.amp.2010.07.007 |
| Bellet, 2013 | repeat population groups, duplicate reports (most recent study included) | EXCLUDED: this abstract was fully published in a publication (Bellet 2015). |
Bellet F Fundamental and Clinical Pharmacology 2013;27(S1):43. |
| Shechtman, 2009 | same data already obtained by other studies | EXCLUDED: A part of these data were probably included in study Mc Kenna 2005, related to SGA (n=151 including 49 risperidone). But Shechtman including in Risperidone meta-analysis (rather than McKenna). |
Shechtman S 20th Annual meeting of the European Network of Teratology Information Services, Florence; May 2009 |
| Garayt, 2009 | same data already obtained by other studies | EXCLUDED: same study that Vial 2009. |
Garayt C 20th Annual meeting of the European Network of Teratology Information Services, Florence; May 2009 |
| Jerling, 1991 | article unavailable | EXCLUDED: article unavailable, also after intensive searches. | |
| Kenar, 2019 | no specific data | EXCLUDED: no detailed results on fetal/neonatal/maternal safety outcomes. |
Kenar Eur. Neuropsychopharmacol. 2019; 29:S175-. 10.1016/j.euroneuro.2019.09.270 |
| Wibroe, 2017 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: No sub-analyse of Atypical antipscychotics. Studied drugs related to the nervous system (ATC code ‘N’), except anesthetics and analgesics |
Wibroe MA Acta Psychiatr Scand 2017;136:177-187 10.1111/acps.12754 |
| Gissler, 2010 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: No sub-analyse on Atypical antipsychotics. The purchase of psychotropic drugs in the three months before pregnancy as a proxy measure of mental health status. |
Gissler M BMC Public Health 2010;10:383 10.1186/1471-2458-10-383 |
| Petersen, 2016 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: no sub-analyse of Atypical antispychotics. In total 495,953 pregnancies in 365,138 women were identified. In the 1–3 months before pregnancy 1051 women were prescribed antipsychotics, 78 lithium and 2046 anticonvulsant mood stabilisers. |
Petersen I Schizophr Res 2016;176:349-356 10.1016/j.schres.2016.07.023 Petersen I Health Technol Assess 2016;20:1-176 10.3310/hta20230 |
| Michielsen, 2014 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: The patients either had an active mental disorder, were taking medication to prevent a relapse, or had a history of postpartum depression or psychosis. |
Michielsen LA Neuropsychiatr Dis Treat 2014;10:13-8 10.2147/NDT.S53430 |
| Manakova, 2011 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: group of new psychotropic drugs included antidepressant as well as antipsychopic. The groups defined by the authors were the opposite: SSRI (exposed group) versus new psychotropic drugs (comparison group) | |
| Moller-Olsen, 2018 | Studies without separate analysis of the considered drug/class from other drugs/class | 'Pregnant women requiring treatment with mood stabilizers or antipsychotics in pregnancy'. 'Additional pregnancy complications included hyperemesis (n = 3), hypertension (n = 2), and vaginal bleeding (n = 2).' |
Moller-Olsen Asia Pac Psychiatry 2018; 10:e12304 10.1111/appy.12304 |
| Schrijver, 2023 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Analysis of antipsychotics as a whole (including both typical and atypical antipsychotics), without distinction between typical and atypical antipsychotics. |
Schrijver Acta Psychiatr Scand 2023; 147:43-53 10.1111/acps.13517 |
| Johnson (Unexposed control), 2012 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: No specific analyse of atypical antipsychotics. The exposed group included First Generation antipsychotics (FGA) and SGA (Second Generation antipsychotics). |
Johnson KC Arch Gen Psychiatry 2012;69:787-94 10.1001/archgenpsychiatry.2012.160 |
| Johnson (Control exposed to other treatments), 2012 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: No specific analyse of atypical antipsychotics. The exposed group included First Generation antipsychotics (FGA) and SGA (Second Generation antipsychotics). |
Johnson KC Arch Gen Psychiatry 2012;69:787-94 10.1001/archgenpsychiatry.2012.160 |
| Frayne, 2017 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: No sub-analyse of Atypical antipscychotics. Studied class: Any psychotropic drug, Antipsychotic alone, Antidepressant alone, Combination. |
Frayne J Aust N Z J Obstet Gynaecol 2017;57:526-532 10.1111/ajo.12621 |
| Chan, 2024 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Analysis of mood stabilizers as a whole (lithium, antipsychotics and mood-stabilizing anticonvulsants), without distinction between substances. |
Chan Psychiatry Res 2024; 339:116050 10.1016/j.psychres.2024.116050 |
| Daud, 2015 | Studies without separate analysis of the considered drug/class from other drugs/class | Subgroup Antipsychotics as a whole (haloperidol, quetiapine, risperidone), without distinction between substances. | |
| Morimoto, 2021 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: antipsychotics studied as a whole without distinction between typicals and atypicals. |
Morimoto CNS Spectr 2021; 26:509-512 10.1017/S1092852920001522 |
| Freeman, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: study related to the impact of obesity on pregnancy outcomes among women with psychiatric disorders, without distinction between treatment. |
Freeman J Psychosom Res 2019; 123:109735 10.1016/j.jpsychores.2019.109735 |
| Galbally, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: maternal and neonatal outcomes reported for the whole sample of severe mental illness women, without distinction between treatment. |
Galbally Eur Neuropsychopharmacol 2019; 29:57-65 10.1016/j.euroneuro.2018.11.1103 |
| Heller, 2017 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: 'other psychopharmacological drugs' (atypical and typical antipsychotics, BZD, lithium and valproate) studied as a whole, without distinction between treatments. |
Heller BMC Pregnancy Childbirth 2017; 17:166 10.1186/s12884-017-1334-4 |
| Matevosyan, 2011 | Studies without separate analysis of the considered drug/class from other drugs/class | Crude odds ratios with 95% CI not containing unity are followed up by adjusting the OR for maternal age, parity, onset of schizophrenia, and length of antipsychotic treatment. |
Matevosyan Arch. Gynecol. Obstet. 2011; 283:141-7 10.1007/s00404-010-1706-8 |
| Kallen, 2012 | Studies without separate analysis of the considered drug/class from other drugs/class | Antipsychotic (ATC code N05A except dixyrazine and prochlorperazine and lithium): most frequent: Olanzapine (65), haloperidol (27).Antipsychotic studied as a whole without distinction between typicals and atypicals. |
Kallen J Clin Psychopharmacol 2012; 32:608-14 10.1097/JCP.0b013e3182668568 |
| Bulbul, 2014 | Studies without separate analysis of the considered drug/class from other drugs/class | Of the patients with Bipolar, 4 amisulpride, 3 olanzapine, 2 haloperidol, 1 risperidone and 3 clonazepam. Among the schizophrenia patients, one of them was given amisulpride. 2 of the patients with OCD were given fluoxetine and 1 citalopram. |
Bulbul, F. Dusunen Adam 2014; 27:21-. 10.5350/DAJPN2014270103 |
| Clements, 2015 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: antipsychotics as a whole, without distinction between typical and atypical. |
Clements CC Mol Psychiatry 2015;20:727-34 10.1038/mp.2014.90 |
| Momen, 2022 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: antipsychotics assessed as a whole or some ATC class (N05AA; N05AB; N05AF; N05AH or N05AX), none corresponding to a atypical antipsychotics. |
Momen Neuropsychopharmacology 2022; 47:759-766 10.1038/s41386-021-01223-y |
| Kanemura, 2020 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: analysis made for medications as a whole (anxiolytics (63), antipsychotics (62), sedatives (50), antidepressants (41), and anticonvulsants (24)), without distinction between subclass of treatments. |
Kanemura Eur J Obstet Gynecol Reprod Biol 2020; 254:226-230 10.1016/j.ejogrb.2020.09.008 |
| Wachman, 2018 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: For Neonatal Abstinence Syndrome (NAS) outcome: Psychiatric medications considered as a whole without distinction between treatments. For Quetiapine: outcomes were continuous (number of days of hospital stay). |
Wachman Drug Alcohol Depend 2018; 192:45-50 10.1016/j.drugalcdep.2018.07.024 |
| Koga, 2019 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: comparison between inpatient and outpatient groups rather than according to Antipsychotics (that include typical and atypical antipsychotics, as a whole). |
Koga, E. Clinical and Experimental Obstetrics and Gynecology 2019; 46:201-. 10.12891/ceog4396.2019 |
| Solé, 2020 | Studies without separate analysis of the considered drug/class from other drugs/class | EXCLUDED: Analysis of antipsychotic drugs as a whole, without distinction between typical or atypical subclass. |
Solé Eur Neuropsychopharmacol 2020; 32:47-55 10.1016/j.euroneuro.2019.12.115 |
| Cohen, 2015 | Review articles, letter to editor, editorial, comments | EXCLUDED: article on the methodology of the registry, without results. |
Cohen J Clin Psychiatry 2015; 76:986-9 10.4088/JCP.14br09418 |
| Kennedy, 2013 | pattern of exposure | EXCLUDED: Data on pattern of exposure without data on maternal/fetal/neonatal outcomes. |
Kennedy Aust N Z J Obstet Gynaecol 2013; 53:544-52 10.1111/ajo.12129 |
| Forrester, 2004 | pattern of exposure | EXCLUDED: Data on pattern of exposure without data on maternal/fetal/neonatal outcomes. | |
| McKenna, 2004 | pattern of exposure | EXCLUDED: Data on pattern of exposure without data on maternal/fetal/neonatal outcomes. | |
| Ladavac, 2007 | pattern of exposure | EXCLUDED: no data related to fetal/maternal/neonate safety. | |
| Gendron, 2009 | pattern of exposure | EXCLUDED: Data on pattern of exposure without data on maternal/fetal/neonatal outcomes. |
Gendron Eur. J. Clin. Pharmacol. 2009; 65:523-31 10.1007/s00228-008-0611-6 |
| Leong, 2017 | pattern of exposure | Study on pattern of exposure (no data on maternal/fetal/neonatal outcomes). |
Leong Can J Psychiatry 2017; 62:543-550 10.1177/0706743717711168 |
| Epstein, 2013 | pattern of exposure | EXCLUDED: Data on pattern of exposure without data on maternal/fetal/neonatal outcomes. |
Epstein Pharmacoepidemiol Drug Saf 2013; 22:794-801 10.1002/pds.3366 |
| Toh, 2013 | pattern of exposure | Study on pattern of exposure (no data on maternal/fetal/neonatal outcomes). |
Toh Arch Womens Ment Health 2013; 16:149-57 10.1007/s00737-013-0330-6 |
| Johnson, 2016 | pattern of exposure | 'The purpose of this project was to examine prescribing practices of antipsychotics on obstetrical floors at our institution. We examined the prevalence, patterns, and appropriateness of prescribing during pregnancy.' |
Johnson Arch Womens Ment Health 2016; 19:705-7 10.1007/s00737-016-0642-4 |
| Hanley, 2014 | pattern of exposure | EXCLUDED: Data on pattern of exposure without data on maternal/fetal/neonatal outcomes. |
Hanley BMC Pregnancy Childbirth 2014; 14:242 10.1186/1471-2393-14-242 |
| Damkier, 2018 | pattern of exposure | EXCLUDED: Data on pattern of exposure without data on maternal/fetal/neonatal outcomes. |
Damkier Br J Clin Pharmacol 2018; 84:2651-2662 10.1111/bcp.13732 |
| Park, 2017 | pattern of exposure | EXCLUDED: study on pattern of exposure (no data on maternal/fetal/neonatal outcomes). |
Park Psychiatr Serv 2017; 68:1112-1119 10.1176/appi.ps.201600408 |
| Illoh, 2018 | pattern of exposure | EXCLUDED: study on pattern of exposure (no data on maternal/fetal/neonatal outcomes). |
Illoh Pharmacoepidemiol Drug Saf 2018; 27:604-611 10.1002/pds.4409 |
| Michel,, 2023 | less than 10 exposed pregnancy | Only 3 pregnancy exposed to CQuetiapine. Due to limitations to the sample size, subgroup analyses were performed for PPIs, SSRIs, and dimenhydrinate only. |
Michel, H. Front. Pharmacol. 2023; 14:652-. 10.3389/fphar.2023.1193317 |
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